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FDA 510(k) Application Details - K093669
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K093669
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
INNVOTEC SURGICAL, INC.
1331 H STREET NW
12TH FLOOR
WASHINGTON, DC 20005 US
Other 510(k) Applications for this Company
Contact
JUSTIN EGGLETON
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
11/27/2009
Decision Date
03/18/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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